NEW DELHI, March 1: The Food and Drugs Administration (FDA) has cleared Ranbaxy Laboratories' anti-ulcer drug,ranitidine, for launch in the USA.Ranbaxy officials said at least 10 new drug applications will be filed by the company with the FDA during this year.The company is also planning to introduce at least 12 more products in the US. In all nine drugs, including Phenobarbitol, Seconal Sodium, Amytal Sodium, Trinal, Morphine Sulphate, Opium Tincture, Codeine Phosphate and Nalfon, will be launched by June, this year.
In the second half of 1998, Ranbaxy plans to launch Cephalexin, Propoxyphene and Netriphylline in the US market. The United States is the largest pharmaceutical market, with estimated 1997 sales of $101 billion.
The company has entered into a 50:50 joint venture with the New Jersey-based Schein Pharmaceuticals Inc, the generics arm of Bayer AG, Germany, for manufacture of Ranitidine.
Director corporate affairs Neel Chatterjee told The Financial Express that with the FDA givingits nod to the launch of ranitidine, the last hurdle to tap the US market had been removed. Ranbaxy expects to launch the drug in the beginning of March, this year. The US is the world's largest market for this drug, accounting for $2.6 billion of the $4-billion global market.
In the first half of 1998, the company expects prescription-product sales in excess of $15 million from the sale of ranitidine and other products, including Cefaclor. In the first month of its launch in January this year, Cefaclor has achieved sales in excess of $500,000. The company will be marketing the generic drug in the US, under the name "Ranbaxy Ranitidine".
Ranbaxy will compete with at least four other US and Canadian drug firms that are marketing generic versions of ranitidine hydrochloride, besides Glaxo's best selling anti-ulcer Zantac.
Copyright © 1998 Indian Express Newspapers (Bombay) Ltd.
